1. The Field of the Invention
The present invention relates to methods for manufacturing a granulated product. More particularly, the present invention relates to methods of using chemical reactions that induce the formation and agglutination of particles so as to produce granules comprised of minerals.
2. The Related Technology
Granular formulations are important for use in various industries, and have been found to be particularly useful in the pharmaceutical, nutraceutical, and dietary supplement industries. Typically, these industries use granular formulations in order to produce consumable products that can be easily packaged and distributed. This includes using the granular formulations during the production of tablet and capsule medicaments that include active ingredients or for a variety of other applications. Granular formulations can be preferred because they are easy to use and handle and can be supplied into various types of manufacturing equipment. In part, the granular formulations are easy to use because they can be configured to be soluble, compactable, and tabletable and can be easily measured and delivered in accurate quantities.
In various processes it can be preferred that the granular formulation include granules that have a minimum diameter, maximum diameter, or range of diameters in order to achieve a desired functionality. As such, previous processes that prepare granular formulations have required milling or grinding solid formulations so that the desired granule particle sizes can be achieved. However, milling and grinding can be a tedious and time consuming process and can require large and expensive equipment. Also, milling and grinding techniques may also provide granular formulations that do not conform to the particle size characteristics, and may provide granules that are either too small or too large. On the other hand, inadequate milling or grinding can be especially problematic to the pharmaceutical and dietary supplement industries because of the necessity for strict compliance with various rules, regulations, and consistent product characterizations that require specific and narrow particle sizes.
Moreover, a typical process that produces a granular formulation can require a number of steps that add to complexity and cost, and may result in granular products that do not conform to specific needs. Such a process can be exemplified by wet granulation processes. A wet granulation process can include mixing an active ingredient and binder in a mixer with a granulating solution or fluid until the desired characteristics are achieved. The desired characteristics can include cohesiveness, malleability, and the ability to be extruded and/or dried.
A dried product can be milled or ground to achieve granules having a maximum particle size. Sometimes an extruded product has to be pelletized in a separate step before being introduced into a grinder or mill that can produce granules having the appropriate size. Additionally, the milling and grinding of a particulate composition can usually result in the formation of powders that contaminate the granular formulations. Even though the powder can be comprised of the same material as the granule, the small particulates can be unacceptable for tablet or capsule preparations. Additionally, particulate compositions that include powders can be difficult to handle because the powders are easily airborne and can cause measuring and delivery errors.
Another problematic process that has been developed for preparing granular formulations is referred to as spray drying granulation. In this process a fluid bed granulation system fluidizes the active ingredient, binders, and optional excipients into a fluidic stream. The fluidized suspension is then sprayed onto the top of a fluidized bed using a spray nozzle. This procedure can use a lot of energy in order to get the active ingredient into the fluidized stream. Also, this procedure can produce a lot of powders and fines that do not conform to the uses of the granular product. Moreover, the granules can be soft and may not perform well during subsequent processing.
The typical granulation processes that produce the granular products start with the active ingredient that is to be granulated. In the instances the active ingredient is a reaction product a chemical reaction may need to be performed in addition to the granulation process. Accordingly, the granulation of a reaction product can be even more complicated, time consuming, and expensive when the reaction has to be performed. Additionally, many chemical reactions produce byproducts that have to be separated from the active ingredient before it can be included in a granulation procedure.
Therefore, it would be advantageous to have an improved granulation procedure that includes fewer steps and does not necessarily require grinding, milling, or spray drying to obtain granules. Additionally, it would be beneficial to have a chemical reaction procedure that can be used in order to produce a granule formulation without requiring grinding, milling, or spray drying to obtain granules.